This study is to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of Niclosamide (DWRX2003) following escalating doses of DWRX2003 administered as an intramuscular injection in healthy volunteers.
Drug: DWRX2003
Intramuscularly injection at pre-defined injection sites
Drug: Placebo
Intramuscularly injection at pre-defined injection sites
Inclusion Criteria:
1. Normal healthy human adult male and female volunteers between 18-45 years (both ages
inclusive) of age.
2. Volunteers who agree to give written informed consent and are willing to participate
in the study.
3. Volunteer having bodyweight minimum of 50 kg.
4. Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive).
Exclusion Criteria:
1. Known allergic to Niclosamide or any component of the formulation and to any other
related drug.
2. History or presence of significant cardiovascular, respiratory, hepatic, renal,
hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or
psychiatric disease.
3. Female volunteers who are nursing mothers/lactating women or are found positive in
beta hCG test.
4. History/ current use of Alcohol or drug abuse.